KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT— 510(k) K854483

Name: FDA 510(k) clearance K854483
Creator: U.S. Food and Drug Administration
Published: 1985-12-11

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K854483 for KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT, Substantially Equivalent on 1985-12-11. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code KTO
Device class: Class 1
Regulation: 21 CFR 866.5530
Advisory panel: Immunology
Date received: 1985-11-07
Decision date: 1985-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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